Zinde Zihin Program to Reduce Alzheimer's Disease Risk in Adults Aged 65 and Older
NCT ID: NCT07244848
Last Updated: 2025-11-24
Study Results
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Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2024-04-01
2024-08-01
Brief Summary
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Detailed Description
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Study Rationale Lifestyle factors such as cognitive stimulation, physical activity, sleep, and social engagement play an important role in cognitive health. Multidomain interventions involving these components may support healthy aging. This study was developed to examine the feasibility of such an intervention in Turkish nursing home settings.
Study Design This is an individually randomized, controlled pretest-posttest study conducted in two public nursing homes. Randomization is performed at the individual level after eligibility screening. The protocol follows CONSORT guidelines for individually randomized trials.
Participants Eligible participants are adults aged 65 years or older with a Mini-Mental State Examination (MMSE) score ≥23 who are able to communicate verbally and volunteer to participate. Exclusion criteria include diagnosed dementia, major psychiatric illness, severe sensory impairment preventing participation, or unwillingness to attend intervention sessions.
Intervention
Eight structured sessions are delivered to the intervention group:
* Orientation and baseline assessment
* Cognitive stimulation activities
* Emotional well-being and social interaction activities
* Physical activity and brain-health education
* Creative expression and art-based engagement
* Nutrition and brain-healthy dietary education
* Sleep education and relaxation techniques
* Reflection, feedback, and post-test assessment
The control group receives routine nursing home activities only.
Outcome Measures
Primary Outcome:
The Alzheimer's Disease Risk Index-Short Form (ANU-ADRI-SF), a self-report instrument assessing demographic, lifestyle, and medical factors associated with Alzheimer's disease risk. Scores are collected at baseline and at 4 weeks.
Secondary Outcomes:
Measures assessing cognitive activity participation and affect-related lifestyle factors, collected at baseline and 4 weeks.
Randomization and Allocation Concealment Participants are randomized using a computer-generated list stratified by institution. Allocation is concealed through sequentially numbered, opaque, sealed envelopes prepared by an independent researcher.
Blinding Due to the nature of the intervention, participants and facilitators cannot be blinded. Outcome assessors and data analysts remain blinded.
Ethics The study was approved by the Burdur Mehmet Akif Ersoy University Ethics Committee (GO 2025/1069). Written informed consent is obtained from all participants.
Data Collection and Timing Baseline and post-intervention assessments are administered individually by the researcher in a private room within the nursing homes.
Statistical Analysis Plan Descriptive statistics and statistical procedures appropriate to the data structure will be applied. Analyses will be conducted according to the predefined analysis plan.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Participants are individually randomized into two parallel groups (intervention and control). The intervention group receives the Zinde Zihin multidomain lifestyle program, delivered in eight structured sessions over four weeks. The program includes cognitive stimulation, physical activity, nutrition education, psychosocial engagement, and sleep/stress management activities. Sessions are group-based and facilitated by a trained researcher. The control group receives routine nursing home activities without any additional structured intervention. Baseline and post-intervention assessments are administered to all participants. The model aims to examine changes in Alzheimer's Disease Risk Index scores and related lifestyle factors under a parallel assignment design.
PREVENTION
SINGLE
Study Groups
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Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention
Participants in the intervention group received the eight-session Zinde Zihin (Fit Mind) multidomain lifestyle program, which combined cognitive training, moderate physical exercise, nutritional education, and psychosocial stimulation. Sessions were conducted twice weekly for four weeks in small group settings at nursing homes.
Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention
The Zinde Zihin (Fit Mind) program is a culturally adapted multidomain lifestyle intervention developed to enhance cognitive health, emotional well-being, and daily functioning in older adults. The program combines four evidence-based components-cognitive training, physical activity, nutritional education, and psychosocial stimulation-delivered in eight 60-75-minute sessions over four weeks. Activities included memory and problem-solving games, balance and stretching exercises, discussions on brain-healthy diets, and group-based art, music, and storytelling exercises to strengthen social engagement and mental resilience.
What distinguishes the Zinde Zihin program from other interventions is its cultural adaptation for Turkish older adults living in institutional settings. It integrates traditional Turkish music, storytelling, and collective art creation to increase emotional connection and sustainability. Sessions were held in small groups at nursing homes and facilitated by trained p
Control Group - Routine Care
Participants assigned to the control group continued their usual daily activities and standard care routines in the nursing home. They did not receive any structured sessions of the Zinde Zihin (Fit Mind) program or other organized lifestyle interventions during the study period.
No interventions assigned to this group
Interventions
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Zinde Zihin (Fit Mind) Multidomain Lifestyle Intervention
The Zinde Zihin (Fit Mind) program is a culturally adapted multidomain lifestyle intervention developed to enhance cognitive health, emotional well-being, and daily functioning in older adults. The program combines four evidence-based components-cognitive training, physical activity, nutritional education, and psychosocial stimulation-delivered in eight 60-75-minute sessions over four weeks. Activities included memory and problem-solving games, balance and stretching exercises, discussions on brain-healthy diets, and group-based art, music, and storytelling exercises to strengthen social engagement and mental resilience.
What distinguishes the Zinde Zihin program from other interventions is its cultural adaptation for Turkish older adults living in institutional settings. It integrates traditional Turkish music, storytelling, and collective art creation to increase emotional connection and sustainability. Sessions were held in small groups at nursing homes and facilitated by trained p
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
65 Years to 80 Years (Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Exclusion Criteria
* History of depression or major psychiatric disorder.
* Physical disability or medical condition prevents participation in exercise.
* Attendance in less than two-thirds of the planned intervention sessions.
65 Years
80 Years
ALL
Yes
Sponsors
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Burdur Mehmet Akif Ersoy University
OTHER
Responsible Party
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Ayse Sezer Balci
Assistant Professor, PhD, RN - Department of Public Health Nursing, Burdur Mehmet Akif Ersoy University
Principal Investigators
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Ayse Sezer Balci, PhD
Role: PRINCIPAL_INVESTIGATOR
Burdur Mehmet Akif Ersoy University
Locations
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Burdur Mehmet Akif Ersoy University Faculty of Health Science
Burdur, , Turkey (Türkiye)
Countries
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Other Identifiers
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Ethics Approval No: GO-2025/10
Identifier Type: OTHER
Identifier Source: secondary_id
MAKU-ZINDEZIHIN-2025
Identifier Type: -
Identifier Source: org_study_id
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